Health Condition 1: null- Polycystic Ovarian Syndrome (PCOS)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosed PCOS as per Rotterdam diagnostic criteria [23] (developed in 2003 to aid clinicians in the systematic and accurate diagnosis of PCOS). It states that two of the following three criteria should be present for a diagnosis: a) oligo-ovulation or anovulation; b) clinical and/or biochemical signs of hyperandrogenism; and c) polycystic ovaries. Furthermore, the likelihood of other similar illnesses (such as Cushingâ??s syndrome) should first be systematically excluded. New criteria have recently been proposed by the Androgen Excess and PCOS Society, which suggest tighter definitions are required by focusing on only two criteria: a) hyperandrogenism (clinical hirsutism or biochemical hyperandrogenaemia, or both); and b) ovarian dysfunction (oligo-ovulation or anovulation, or polycystic ovaries, or both). 2. Age 18-45 years 3. Symptomatic for at least last 3 months 4. Patients taking oral contraceptive pills (OCPs) will be advised to stop pills till it exhaust for the ongoing cycle, followed by re-assessment of symptoms in the next cycle enrolment 5. Patients under hormonal replacement therapy (HRT) to be included after a washout period of 3 months 6. Patients with known but controlled systemic diseases with medication 7. Ability to read Bengali 8. Patients giving written consent to participate
Exclusion criteria
Exclusion criteria: 1. Unevaluated gynaecological abnormalities; e.g. unexplained vaginal bleeding, cervical dysplasia, pelvic inflammatory diseases (PID) within one month, patients with suspicious adenomyosis, gross developmental defect or congenital abnormalities of the uterus etc. 2. Genito-urinary tract malignancy 3. Patients desiring immediate surgical management for PCOS 4. Patients insisting to use OCPs 5. Patients with psychiatric diseases 6. Pregnancy and lactation 7. Cases suffering from uncontrolled systemic illness or life-threatening infections or any vital organ failure 8. Cases already undergoing homoeopathic treatment for any chronic disease 9. Substance abuse and/or dependence 10. Self-reported immune-compromised state
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pelvic/transvaginal ultrasound and blood LH:FSH levelTimepoint: Baseline and after 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| EQ-5D-5L questionnaire; validated Bengali versionTimepoint: Baseline, after 3 and 6 months;Modified PCOS questionnaire (MPCOSQ); translated Bengali versionTimepoint: Baseline, after 3 and 6 months | — |
Countries
India
Contacts
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India